DCMA ISO 9001:2000 / SAE AS9100 Rev. B AUDIT CHECKLIST October 7 200! CLAUSE !.1 General requirements "e#er$% C%$&'e De'cr()t(o# The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall a) identify the processes needed for the quality management system and their application throughout the organization (see .!), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. "here an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. #ontrol of such outsourced processes shall be identified within the quality management system. $%T&' rocesses needed for the quality quality management syst system em referred to above should include include processes for management management activities, provision provision of resources, product realization and measurement.
Clause #
DESCRIPTION
4.1
General Requirement as !"e $%a'(a!' es!a)l's"e*+ *,u-e!e*+ '-le-e!e*+ -a'!a'e* a* ,!'uall '-$0e* a Qual'! Maa%e-e! Ss!e- ' a,,$*a,e '!" !"e ISO 23314 5333 s!a*a$*6 Des !"e $%a'(a!'4 a7 I*e!'8'e* !"e $,esses ee*e* 8$ 8$ !"e Qual'! Maa%e-e! Ss!e-6
)7 De!e$-'e* !"e se9ue,e a* '!e$a,!' 8 !"ese $,esses6 ,7 De!e$-'e* ,$'!e$'a a* -e!"*s $e9u'$e* ! esu$e e88e,!'0e e$a!' a* ,!$l 8 !"e '*e!'8'e* $,esses: *7 Esu$e a0a'la)'l'! 8 $esu$,es a* '8$-a!' $e9u'$e* ! su$! !"e e$a!' a* -'!$'% 8 $,esses: e7 -easu$e+ -'!$ a* aal(e !"e $,esses a* '-le-e! a,!' ! a,"'e0e lae* $esul!s a* ,!'ual '-$0e-e!.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
Clause #
DESCRIPTION
4.1
General Requirement as !"e $%a'(a!' es!a)l's"e*+ *,u-e!e*+ '-le-e!e*+ -a'!a'e* a* ,!'uall '-$0e* a Qual'! Maa%e-e! Ss!e- ' a,,$*a,e '!" !"e ISO 23314 5333 s!a*a$*6 Des !"e $%a'(a!'4 a7 I*e!'8'e* !"e $,esses ee*e* 8$ 8$ !"e Qual'! Maa%e-e! Ss!e-6
)7 De!e$-'e* !"e se9ue,e a* '!e$a,!' 8 !"ese $,esses6 ,7 De!e$-'e* ,$'!e$'a a* -e!"*s $e9u'$e* ! esu$e e88e,!'0e e$a!' a* ,!$l 8 !"e '*e!'8'e* $,esses: *7 Esu$e a0a'la)'l'! 8 $esu$,es a* '8$-a!' $e9u'$e* ! su$! !"e e$a!' a* -'!$'% 8 $,esses: e7 -easu$e+ -'!$ a* aal(e !"e $,esses a* '-le-e! a,!' ! a,"'e0e lae* $esul!s a* ,!'ual '-$0e-e!.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE !.2 Documentation requirements S&b*c%$&'e 4.2.1 General "e#er$% S&b*c%$&'e De'cr()t(o#: The quality management system documentation shall include a) documented statements of a quality policy and quality obectives, b) a quality manual, c) documented procedures required by this International Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see *.!.*). $%T& "here the term +documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. $%T& ! The e-tent of the quality management system system documentation can differ from one organization organization to another due to a)
the size size of organi organizati zation on and type of of activities activities,,
b)
the comple-ity comple-ity of processes and their their interactions, interactions, and
c)
the competence of personnel.
$%T& The documentation can be in any form or type of medium.
Clause
4.2.1
DESCRIPTION
General Des !"e $%a'(a!' "a0e *,u-e!e* s!a!e-e!s 8 !"e'$ 9ual'! l',6 Des !"e $%a'(a!' "a0e *,u-e!e* s!a!e-e!s 8 !"e'$ 9ual'! )
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 4.2.2 Quality manual "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and ustification for any e-clusions (see .!), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. Clause
4.2.2
DESCRIPTION
Quality manual as !"e $%a'(a!' es!a)l's"e* a* -a'!a'e* a 9ual'! -aual6 Des !"e 9ual'! -aual 4 a7 $e8le,! !"e s,e 8 !"e $%a'(a!'s Qual'! Maa%e-e! Ss!e- ?QMS76 )7 *e!a'l a e@,lus's ?see 1.57 ! Clause a* e@$ess
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 4.2.3 Control of documents "e#er$% S&b*c%$&'e De'cr()t(o#: /ocuments required by the quality management system shall be controlled. 0ecords are a special type of document and shall be controlled according to the requirements given in *.!.*. 1 documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re2approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of e-ternal origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
Clause #
DESCRIPTION
4.2.3
Control of documents as a *,u-e!e* $,e*u$e )ee es!a)l's"e* ! ,!$l all *,u-e!s6 Des !"e $,e*u$e ',lu*e ,!$ls 8$4 a7 a$0al 8 *,u-e!s 8$ a*e9ua, $'$ ! 'ssue6 )7 $e0'e+ u*a!e+ a* ?as e,essa$7 $ea$0al 8 *,u-e!s6 ,7 esu$'% ,"a%es a* ,u$$e! $e0's' s!a!us 8 *,u-e!s a$e '*e!'8'e*6 *7 esu$'% !"a! $ele0a! 0e$s's 8 al',a)le *,u-e!s a$e a0a'la)le a! '!s 8 use: e7 esu$'% !"a! *,u-e!s $e-a' le%')le a* $ea*'l '*e!'8'a)le: 87 esu$'% !"a! *,u-e!s 8 e@!e$al $'%' a$e '*e!'8'e* a* !"e'$ *'s!$')u!' ,!$lle*: %7 $e0e!'% !"e u'!e*e* use 8 )sle!e *,u-e!s+ a* al'% su'!a)le '*e!'8',a!' ! !"e- '8 !"e a$e $e!a'e* 8$ a u$se. H$' te or$#(4$t(o# coor(#$te oc&e#t c$#e' 3(t c&'toer' $#/or re&%$tor $&tor(t(e' (# $ccor$#ce 3(t co#tr$ct or re&%$tor re-&(ree#t'5
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 4.2.4 Control of records "e#er$% S&b*c%$&'e De'cr()t(o#: 0ecords shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. 0ecords shall remain legible, readily identifiable and retrievable. 1 documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Clause # DESCRIPTION
4.2.4
AS9100
4.2.4 Control of records as !"e $%a'(a!' '*e!'8'e* !"e $e,$*s $e9u'$e* ! $0'*e e0'*e,e 8 ,8$-'! ! $e9u'$e-e!s a* !"e e88e,!'0e e$a!' 8 !"e Qual'! Maa%e-e! Ss!e-6 ="a! -e!"*s *es !"e $%a'(a!' use ! esu$e !"a! $e,$*s $e-a' le%')le+ $ea*'l '*e!'8'a)le a* $e!$'e0a)le6 ="a! *,u-e!e* $,e*u$es *e8'e !"e ,!$ls use* 8$ !"e '*e!'8',a!'+ s!$a%e+ $!e,!'+ $e!$'e0al+ $e!e!' !'-e+ a* *'ss'!' 8 $e,$*s6 A''&re oc&e#te )roce&re' e+(#e te eto +or co#tro%%(# recor' t$t $re cre$te b $#/or 6e)t b '&))%(er'. A''&re recor' $re $v$(%$b%e +or rev(e3 b c&'toer' $# re&%$tor $&tor(t(e' (# $ccor$#ce 3(t co#tr$ct or re&%$tor re-&(ree#t'.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
Clause
DESCRIPTION
4.3 4.3 Configuration Management AS9100 Co#+(&r$t(o# M$#$ee#t: er(+ te or$#(4$t(o# $' e't$b%('e $# oc&e#t' $ co#+(&r$t(o# $#$ee#t )roce'' $e-&$te to te )ro&ct.
8OTE "&($#ce o# co#+(&r$t(o# $#$ee#t (' (ve# (# ISO 10007.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE 5 Management responsiility CLAUSE 5.1. Management commitment "e#er$% C%$&'e De'cr()t(o# Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality obectives are established, d) conducting management reviews, and e) ensuring the availability of resources. Clause #
DESCRIPTION
5.1
Management commitment Is !"e$e e0'*e,e 8 ,--'!-e! ) ! -aa%e-e! !a$*s !"e *e0el-e!+ '-le-e!a!' a* '-$0e-e! 8 !"e Qual'! Maa%e-e! Ss!e-. Des !"e ! -aa%e-e! ,--u',a!e ! !"e $%a'(a!' !"e '-$!a,e 8 -ee!'% ,us!-e$s+ s!a!u!$ a* $e%ula!$ $e9u'$e-e!s6 as !"e $%a'(a!' es!a)l's"'% a 9ual'! l',6 ="a! a$e !"e 9ual'! )
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE 5.2 Customer focus "e#er$% C%$&'e De'cr()t(o# Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 3.!. and 4.!.). Clause #
DESCRIPTION
5.2
Customer focus ="a! -e!"*l%'es "as ! -aa%e-e! *e0ele* ! esu$e !"a! ,us!-e$ $e9u'$e-e!s "a0e )ee *e!e$-'e*6 ="a! -e!"*l%'es "as ! -aa%e-e! *e0ele* ! esu$e ,us!-e$ $e9u'$e-e!s "a0e )ee -e!6 * !"ese -e!"*l%'es esu$e ! -aa%e-e!s %als ! e"a,e ,us!-e$ sa!'s8a,!' a$e a,"'e0e*6 ="a! -e!"*l%'es *es ! -aa%e-e! e-l ! e"a,e ,us!-e$ sa!'s8a,!' '!" !"e $*u,! $ se$0',e !"e $0'*e6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE
5.3 Quality policy
"e#er$% C%$&'e De'cr()t(o# Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framewor5 for establishing and reviewing quality obectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability. Clause # DESCRIPTION
5.3
Quality policy a7 as ! -aa%e-e! es!a)l's"e* a 9ual'! l',6 )7 Des !"e 9ual'! l', ',lu*e a s!a!e-e! 8 a ,--'!-e! ! -ee!'% $e9u'$e-e!s+ a* ,!'ual '-$0e-e! 8 !"e 9ual'! ss!e-6 ,7 Des !"e 9ual'! l', $0'*e a 8$a-e$B 8$ es!a)l's"'% a* $e0'e'% 9ual'! )
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE 5.4 !lanning S&b*c%$&'e 5.4.1 Quality o"ecti#es "e#er$% S&b*c%$&'e De'cr()t(o#: Top management shall ensure that quality obectives, including those needed to meet requirements for product (see 3. a) are established at relevant functions and levels within the organization. The quality obectives shall be measurable and consistent with the quality policy. Clause #
DESCRIPTION
.!.1
Quality o"ecti#es A$e 9ual'! )
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 5.4.2 Quality management system planning "e#er$% S&b*c%$&'e De'cr()t(o#: Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in *., as well as the quality obectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
Clause #
DESCRIPTION
.!.2
Quality management system planning ="a! l',+ $,ess+ $ $,e*u$e 's use* ! esu$e* !"a! "e la'% !"e 9ual'! -aa%e-e! ss!e- ?QMS7+ !"e ss!e- ,$ea!e* $e8le,!s4 a7 !"se $e9u'$e-e!s '*e!'8'e* ' ,lause >.16 )7 !"e '*e!'8'e* 9ual'! )
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE 5.5 Responsiility$ aut%ority and communication S&b*c%$&'e 5.5.1 Responsiility and aut%ority "e#er$% S&b*c%$&'e De'cr()t(o#: Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. Clause #
DESCRIPTION
..1
Responsiility and aut%ority a0e $ess')'l'!'es a* au!"$'!'es )ee *e8'e* a* ,--u',a!e* ! !"se '0l0e* ' !"e e88e,!'0e e$a!' 8 !"e Qual'! Maa%e-e! Ss!e-6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 5.5.2 Management representati#e "e#er$% S&b*c%$&'e De'cr()t(o#: Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the organization. $%T& The responsibility of a management representative can include liaison with e-ternal parties on matters r elating to the quality management system.
Clause #
DESCRIPTION
..2
Management representati#e as a -e-)e$ 8 -aa%e-e! )ee a'!e* as a HMaa%e-e! Re$ese!a!'0e ) ! -aa%e-e!6 Des !"e Maa%e-e! Re$ese!a!'0e "a0e $ess')'l'! a* au!"$'! !"a! ',lu*es4 a7 esu$'% !"a! !"e $,esses 8 !"e Qual'! Maa%e-e! Ss!e- a$e es!a)l's"e* '-le-e!e* a* -a'!a'e*. )7 $e$!'% ! ! -aa%e-e! !"e e$8$-a,e 8 !"e Qual'! Maa%e-e! Ss!e-+ ',lu*'% ee*s 8$ '-$0e-e!. ,7 $-!'% aa$eess 8 ,us!-e$ $e9u'$e-e!s !"$u%"u! !"e $%a'(a!'.
AS9100
, te or$#(4$t(o#$% +reeo to $re'' $tter' re%$t(# to -&$%(t.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 5.5.3 &nternal communication "e#er$% S&b*c%$&'e De'cr()t(o#: Top management shall ensure that appropriate communication processes are established within the organization and that communication ta5es place regarding the effectiveness of the quality management system. Clause #
DESCRIPTION
5.5.3
&nternal communication ="a! ,--u',a!' $,ess ?es7 / -e!"*s a$e use* ! esu$e !"a! 0a$'us le0els a* 8u,!'s a$e aa$e 8 !"e e88e,!'0eess 8 !"e Qual'! Maa%e-e! Ss!e-. ="a! ,--u',a!' $,ess ?es7 /-e!"*s a$e use* ! esu$e !"a! 0a$'us le0els a* 8u,!'s a$e ,--u',a!'% '!" ea," !"e$ a)u! !"e e88e,!'0eess 8 !"e Qual'! Maa%e-e! Ss!e-.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE 5.' Management re#ie( S&b*c%$&'e 5.'.1 General "e#er$% S&b*c%$&'e De'cr()t(o#: Top management shall review the organization6s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality obectives. 0ecords from management reviews shall be maintained (see *.!.*). Clause #
DESCRIPTION
5.'.1
General Des !"e ! -aa%e-e! $e0'e !"e Qual'! Maa%e-e! Ss!e- ! esu$e '!s ,!'u'% su'!a)'l'!+ a*e9ua, a* e88e,!'0eess6 A$e !"e $e0'e ,*u,!e* a! lae* '!e$0als6 A$e assess'% $!u'!'es ! '-$0e !"e QMS *'s,usse* *u$'% !"e -aa%e-e! $e0'e6 A$e $e,$*s 8$- -aa%e-e! $e0'es -a'!a'e*6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 5.'.2 Re#ie( input "e#er$% S&b*c%$&'e De'cr()t(o#: The input to management review shall include information on a) results of audits, b) customer feedbac5, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow2up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement. Clause #
DESCRIPTION
5.'.2
Re#ie( input Des -aa%e-e! $e0'e 'u! ',lu*e4 a7 $esul!s 8 au*'!s6 )7 ,us!-e$ 8ee*)a,B6 ,7 $,ess e$8$-a,e a* $*u,! ,8$-a,e6 *7 s!a!us 8 $e0e!a!'0e a* ,$$e,!'0e a,!'s6 e7 8llu a,!'s 8$- $e0'us -aa%e-e! $e0'es6 8 7 ,"a%es !"a! ,ul* a88e,! !"e 9ual'! -aa%e-e! ss!e-6 %7 $e,--e*a!'s 8$ '-$0e-e!6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 5.'.3 Re#ie( output "e#er$% S&b*c%$&'e De'cr()t(o#: The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs.
Clause # DESCRIPTION 5.'.3
Re#ie( output Des !"e u!u! 8$- -aa%e-e! $e0'e ',lu*e a,!'s $ela!e* !4 a7 '-$0e-e!s ! !"e Qual'! Maa%e-e! Ss!ea* '!s $,esses6 )7 '-$0e-e!s ! $*u,! $ela!e* ! ,us!-e$ $e9u'$e-e!s6 ,7 $esu$,e ee*s6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE ' Resource management CLAUSE '.1 !ro#ision of resources The organization shall determine and provide the resources needed a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. Clause #
DESCRIPTION
'.1
!ro#ision of resources as !"e $%a'(a!' '-le-e! -e!"*s ! *e!e$-'e a* $0'*e $esu$,es ee*e* !4
a7 '-le-e! a* -a'!a' !"e Qual'! Maa%e-e! Ss!e-6 )7 ,!'uall '-$0e !"e Qual'! Maa%e-e! Ss!e- e88e,!'0eess6 ,7 e"a,e ,us!-e$ sa!'s8a,!' ) -ee!'% ,us!-e$ $e9u'$e-e!s.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE '.2 )uman resources S&b*c%$&'e '.2.1 General "e#er$% S&b*c%$&'e De'cr()t(o#: ersonnel performing wor5 affecting product quality shall be competent on the basis of appropriate education, training, s5ills and e-perience. Clause #
DESCRIPTION
.2.1
"e#er$% a$e e$sel e$8$-'% $B e88e,!'% $*u,! 9ual'! *e!e$-'e* ! )e ,-e!e!6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e .2.2 Competence$ a(areness and training "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall a) determine the necessary competence for personnel performing wor5 affecting product quality, b) provide training or ta5e other actions to satisfy these needs, c) evaluate the effectiveness of the actions ta5en, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality obectives, and e) maintain appropriate records of education, training, s5ills and e-perience (see *.!.*). Clause #
DESCRIPTION
.2.2
Co)ete#ce $3$re#e'' $# tr$(#(# A$e ,-e!e, ee*s 8$ e$sel e$8$-'% $B a88e,!'% 9ual'! '*e!'8'e*6 ="a! a,!'?s7 a$e !aBe ! sa!'s8 !"e '*'0'*ualsJ ee* 8$ ,-e!e,6 *es !"e $%a'(a!' e0alua!e !"e e88e,!'0eess 8 !"e a,!'?s7 !aBe ! 0al'*a!e !"a! !"e $e9u'$e* ,-e!e, "as )ee a,"'e0e*6 *es !"e $%a'(a!' esu$e !"a! '!s e-lees a$e aa$e 8 !"e $ele0a,e a* '-$!a,e 8 !"e'$ a,!'0'!'es a* " !"e ,!$')u!e ! !"e a,"'e0e-e! 8 9ual'! ).5.>7
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE
'.3 &nfrastructure
"e#er$% C%$&'e De'cr()t(o# The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) buildings, wor5space and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport or communication). Clause #
DESCRIPTION
'.3
&nfrastructure as !"e '8$as!$u,!u$e ee*e* ! a,"'e0e !"e ,8$-'! 8 $*u,! $e9u'$e-e!s )ee '*e!'8'e* a* $0'*e* ',lu*'%4 a7 )u'l*'%s+ $Bsa,e a* ass,'a!e* u!'l'!'es6 )7 $,ess e9u'-e! )!" "a$*a$e a* s8!a$e ,7 su$!'% se$0',es *7 Is !"e '*e!'8'e* '8$as!$u,!u$e -a'!a'e* ! a,"'e0e ,!'ue* ,8$-'! ! !"e $*u,! $e9u'$e-e!s6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE '.4 *or+ en#ironment "e#er$% C%$&'e De'cr()t(o# The organization shall determine and manage the wor5 environment needed to achieve conformity to product requirements. Clause #
DESCRIPTION
'.4
*or+ en#ironment as !"e $%a'(a!' *e!e$-'e* !"e $B e0'$-e!?s7 ee*e* ! a,"'e0e ,8$-'! ! $*u,! $e9u'$e-e!s6 *es !"e $%a'(a!' -aa%e !"e '*e!'8'e* $B e0'$-e!?s7 ! a,"'e0e ,!'ue* ,8$-'! ! $*u,! $e9u'$e-e!s6
AS9100
8OTE Co#+or$#ce +$ctor' to be co#'(ere (#c%&e te)er$t&re &((t %(t(# c%e$#%(#e'' )rotect(o# +ro e%ectro't$t(c ('c$re etc.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE , !roduct reali-ation CLAUSE ,.1 !lanning of product reali-ation "e#er$% C%$&'e De'cr()t(o# The organization shall plan and develop the processes needed for product realization. lanning of product realization shall be consistent with the requirements of the other processes of the quality management system (see *.). In planning product realization, the organization shall determine the following, as appropriate' a) quality obectives and requirements for the product7 b) the need to establish processes, documents, and provide resources specific to the product7 c) required verification, validation, validation, monitoring, inspection and test activities activities specific to the product and the criteria for product acceptance7 d) records needed to provide evidence that the realization processes and resulting product meet requirements (see *.!.*) The output of this planning shall be in a form suitable for the organization6s method of operations. $%T& 1 document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, proect or contract, can be referred to as a quality plan. $%T& ! The organization may also apply the requirements given in 3. to the development of product realization processes. processes.
Clause #
DESCRIPTION
,.1
!lanning of of pr product re reali-ation as !"e $%a'(a!' *e!e$-'e* !"e 8ll'%+ as a$$'a!e+ ' la'% !"e $,esses 8$ $eal'(a!' 8 $*u,!4 a7 9ual'! )
AS9100
A$e !"e$e a e@,lus's ?1.57 al'e* ) !"e $%a'(a!' !"e $e9u'$e-e!s ' se,!' .3 8 ISO 2331 5333 a* a$e su," e@,lus's *e!a'le* ' !"e Qual'! Maual ?>.5.57 '!"
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE ,.2 Customerrelated processes S&b*c%$&'e 7.2.1 Determination of requirements related to t%e product "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall determine a) b) c) d)
requirements specified specified by the customer, including the the requirements for delivery and post2delivery post2delivery activities, activities, requirements not not stated by the customer customer but necessary necessary for specified specified or intended intended use, where where 5nown, statutory statutory and and regulatory regulatory requirem requirements ents related related to the product product,, and and addition additional al requiremen requirements ts determined determined by the organiz organization ation..
Clause #
,.2. ,.2.1 1
DESCRIPTION
Dete Determ rmin inat atio ion n of requ requir irem emen ents ts rel relat ated ed to to t%e t%e product A$e $,esses es!a)l's"e* ) !"e $%a'(a!' ! *e!e$-'e ,us!-e$ $e9u'$e-e!s ',lu*'%4 a7 $*u,! $e9u'$e-e!s se,'8'e* ) !"e ,us!-e$+ ',lu*'% $e9u'$e-e!s 8$ *el'0e$ a* s!*el'0e$ a,!'0'!'es6 )7 $*u,! $e9u'$e-e!s ! se,'8'e* ) !"e ,us!-e$ )u! e,essa$ 8$ '!e*e* $ se,'8'e* use6 ,7 $e%ula!$ a* s!a!u!$ $e9u'$e-e!s $ela!e* ! $*u,!6 *7 a**'!'al $e9u'$e-e!s as *e!e$-'e* ) !"e $%a'(a!'6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e 7.2.2 Re#ie( of requirements related to t%e product. "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall review the requirements related to the product. This review shall be conducted prior to the organization8s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that a) product requirements are defined b) contract or order requirements differing from those previously e-pressed are resolved, and c) the organization has the ability to meet the defined requirements. 0ecords of the results of the review and actions arising from the review shall be maintained (see *.!.*). "here the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance. "here product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. $%T& In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
Clause #
DESCRIPTION
,.2.2
Re#ie( of requirements related to t%e product. Des !"e $%a'(a!' $e0'e ,us!-e$ $e9u'$e-e!s $'$ ! ,--'!!'% ! sul !"e $*u,! ! !"e ,us!-e$6 Des !"'s $e0'e e@!e* ! 4 a7 su)-'ss' 8 !e*e$s6 )7 a,,e!a,e 8 ,!$a,!s $ $*e$s6 ,7 a,,e!a,e 8 ,"a%es ! !"e ,!$a,!s6 *7 a,,e!a,e 8 ,"a%es ! $*e$s6 Des !"e $e0'e $,ess esu$e !"a!4 a7 $*u,! $e9u'$e-e!s a$e *e8'e*6 )7 ,!$a,! $ $*e$ $e9u'$e-e!s *'88e$'% 8$!"se $e0'usl e@$esse* a$e $esl0e*6 ,7 !"e $%a'(a!' "as !"e a)'l'! ! -ee! *e8'e* $e9u'$e-e!s6 , r('6' ;e.. #e3 tec#o%o 'ort e%(ver t(e 'c$%e, $re $re''e5 Des !"e $e0'e $,esses esu$e !"a! "e $*u,! $e9u'$e-e! ,"a%es a$e -a*e4 a7 a-e*-e!s a$e -a*e ! $ele0a! *,u-e!s6 )7 $ele0a! e$sel ' !"e $%a'(a!' a$e -a*e aa$e 8 !"e ,"a%e* $e9u'$e-e!s6
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e ,.2.3 Customer communication "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedbac5, including customer complaints. Clause #
DESCRIPTION
,.2.3
Customer communication a0e a$$a%e-e!s 8$ ,--u',a!' )ee *e!e$-'e* a* '-le-e!e* ) !"e $%a'(a!' $ela!'% !4 a7 $*u,! '8$-a!'6 )7 e9u'$'es+ ,!$a,!s $ $*e$ "a*l'%+ ',lu*'% a-e*-e!s6 ,7 ,us!-e$ 8ee*)a,B+ ',lu*'% ,us!-e$ ,-la'!s6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE ,.3 Design and de#elopment S&b*c%$&'e ,.3.1 Design and de#elopment planning "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall plan and control the design and development of product. /uring the design and development planning, the organization shall determine a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. lanning output shall be updated, as appropriate, as the design and development progresses. Clause #
DESCRIPTION
,.3.1
Design and de#elopment planning Des !"e $%a'(a!' la a* ,!$l *es'% a* / $ *e0el-e! 8 !"e $*u,!6 Des !"e *es'% a* / $ *e0el-e! la'% $,ess *e!e$-'e4 a7 !"e s!a%es 8 *es'% a* / $ *e0el-e! $,esses6 I' te 'e-&e#c(# re-&(re 'te)' ()ort$#t 't$e' $# eto o+ co#+(&r$t(o# co#tro% $re''e5 )7 $e0'e+ 0e$'8',a!' a* 0al'*a!' a,!'0'!'es a$$'a!e ! ea," *es'% a* / $ *e0el-e! s!a%e6 ,7 $ess')'l'!'es a* au!"$'!'es 8$ *es'% a* / $ *e0el-e! a,!'0'!'es6 A''&re b$'e o# co)%e<(t te or$#(4$t(o# (ve' co#'(er$t(o# to te +o%%o3(# $ct(v(t(e': 'tr&ct&r(# te e'(# e++ort (#to '(#(+(c$#t e%ee#t'= H$ve te'e e%ee#t' $# t$'6' $re''e te #ece''$r re'o&rce' +or e'(# $# eve%o)e#t5 H$' $ re')o#'(b%e )er'o# bee# (e#t(+(e to $''&re e'(# co#te#t (#)&t $t$ )%$##(# co#'tr$(#t'
AS9100
AS9100
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
AS9100
$# )er+or$#ce co#(t(o#' bee# $re''e5 H$' te (#)&t $t$ +or e$c e%ee#t bee# rev(e3e to e#'&re co#'('te#c 3(t re-&(ree#t' $# )er+or$#ce co#(t(o#' bee# $re''e5 H$' te (#)&t $t$ +or e$c e%ee#t bee# rev(e3e to e#'&re co#'('te#c 3(t re-&(ree#t'5 *es !"e $%a'(a!' -aa%e '!e$8a,es )e!ee *'88e$e! %$us '0l0e* ' *es'% a* / $ *e0el-e! ! esu$e e88e,!'0e ,--u',a!' a* ,la$'! 8 $ess')'l'!'es6 a$e !"e *es'% a* / $ *e0el-e! la'% u!u! u*a!e*+ as a$$'a!e+ as !"e *es'% a* / $ *e0el-e! $%$esses6 A''&re te (++ere#t e'(# $# eve%o)e#t t$'6' to be co)%ete $re e+(#e $ccor(# to re-&(re '$+et or +ct(o#$% re-&(ree#t' o+ te )ro&ct (# $ccor$#ce 3(t c&'toer $#/or re&%$tor $&tor(t re-&(ree#t'.
S&b*c%$&'e ,.3.2 Design and de#elopment inputs "e#er$% S&b*c%$&'e De'cr()t(o#: Inputs relating to product requirements shall be determined and records maintained (see *.!.*). These inputs shall include a) functional and performance requirements, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development. These inputs shall be reviewed for adequacy. 0equirements shall be complete, unambiguous and not in conflict with each other. Clause #
DESCRIPTION
,.3.2
Design and de#elopment inputs A$e 'u!s $ela!'% ! $*u,! $e9u'$e-e!s *e8'e*+ *,u-e!e* a* $e0'ee* 8$ a*e9ua,6 Des !"e *es'% a* / $ *e0el-e! 'u! ',lu*e4 a7 8u,!'al a* e$8$-a,e $e9u'$e-e!s6 )7 8u,!'al a* e$8$-a,e $e9u'$e-e!s6 ,7 al',a)le '8$-a!' *e$'0e* 8$- $e0'us s'-'la$ *es'% a* / $ *e0el-e!6 *7 a !"e$ $e9u'$e-e!s esse!'al 8$ *es'%6 A$e all ',-le!e+ a- )'%uus $ ,8l',!'% $e9u'$e-e!s '*e!'8'e* *u$'% $e0'e a* $esl0e*6 A$e !"e 'u!s $ela!e* ! *es'% 'u! $e,$*e* a* -a'!a'e*6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e ,.3.3 Design and de#elopment outputs "e#er$% S&b*c%$&'e De'cr()t(o#: The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. /esign and development outputs shall a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production and for service provision, c) contain or reference product acceptance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use. Clause #
DESCRIPTION
,.3.3
Design and de#elopment outputs Des !"e $%a'(a!' *,u-e! *es'% u!u!s ' a -ae$ !"a! ea)les 0e$'8',a!' a%a's! !"e *es'% a* / $ *e0el-e! 'u!s6 Des !"e *es'% a* / $ *e0el-e! u!u!4 a7 -ee! !"e *es'% 'u! $e9u'$e-e!s6 )7 $0'*e a$$'a!e '8$-a!' 8$ u$,"as'%+ $*u,!' a* se$0',e $0's's6 ,7 ,!a' $ $e8e$e,e $*u,! a,,e!a,e ,$'!e$'a6 *7 se,'8 !"e ,"a$a,!e$'s!',s 8 !"e $*u,! !"a! a$e esse!'al ! '!s sa8e a* $e$ use6 e,er(+ 6e c$r$cter('t(c' 3e# $))%(c$b%e (# $ccor$#ce 3(t e'(# or co#tr$ct re-&(ree#t' $re (e#t(+(e. H$' '(#(+(c$#t $t$ re-&(re to $%%o3 te )ro&ct to be (e#t(+(e $#&+$ct&re (#')ecte &'e $# $(#t$(#e bee# e+(#e b te or$#(4$t(o#5 (.e.: r$3(#' )$rt %('t' ')ec(+(c$t(o#'= $ %('t(# o+ to'e r$3(#' )$rt %('t' $# ')ec(+(c$t(o#' #ece''$r to e+(#e te co#+(&r$t(o# $# te e'(# +e$t&re' o+ te )ro&ct= e, (#+or$t(o# o# $ter($% )roce''e' t)e o+ $#&+$ct&r(# $# $''eb% o+ te )ro&ct to $''&re $ co)%($#t )ro&ct. A$e all *es'% a* / $ *e0el-e! u!u!s a$0e* $'$ ! $elease6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e ,.3.4 Design and de#elopment re#ie( "e#er$% S&b*c%$&'e De'cr()t(o#: 1t suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 3..) a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. articipants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. 0ecords of the results of the reviews and any necessary actions shall be maintained (see *.!.*). Clause #
DESCRIPTION
.;.>
Des'% a* *e0el-e! $e0'e Des !"e $%a'(a!' '*e!'8 su'!a)le s!a%es 8$ ss!e-a!', $e0'es 8 *es'% a* / $ *e0el-e! !4 a7 e0alua!e !"e a)'l'! ! -ee! !"e $e9u'$e-e!s6 )7 '*e!'8 $)le-s a* $se 8llu a,!'s a* c . to $&tor(4e )rocee(# to te #e
AS9100
Des !"e a$!','a!s ' su," $e0'es ',lu*e $e$ese!a!'0es 8 8u,!'s ,,e$e* '!" !"e *es'% a* / $ *e0el-e! s!a%e?s7 )e'% $e0'ee*6 a0e !"e ss!e-a!', $e0'es )ee e$8$-e* ' a,,$*a,e '!" !"e lae* a$$a%e-e!s6 A$e !"e $esul!s 8 $e0'e a* su)se9ue! 8llu a,!'s $e,$*e* a* -a'!a'e*6 ?>.5.>7
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e ,.3.5 Design and de#elopment #erification "e#er$% S&b*c%$&'e De'cr()t(o#: 9erification shall be performed in accordance with planned arrangements (see 3..) to ensure that the design and development outputs have met the design and development input requirements. 0ecords of the results of the verification and any necessary actions shall be maintained (see *.!.*).
Clause #
DESCRIPTION
,.3.5
Design and de#elopment #erification A$e *es'%s a* / $ *e0el-e! 0e$'8',a!'s e$8$-e* ! esu$e !"e u!u!s -ee! !"e *es'% a* / $ *e0el-e! 'u! $e9u'$e-e!s6 8OTE: De'(# $#/or eve%o)e#t $''&r$#ce $ (#c%&e te +o%%o3(#: co)%et(# $%ter#$t(ve c$%c&%$t(o#' 8e3 e'(# co)$r('o# 3(t $ '((%$r )rove# e'(# 3ere )o''(b%e co#&ct(# te't' $# eo#'tr$t(o#' $# rev(e3(# te e'(# 't$e oc&e#t' be+ore re%e$'e5
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e ,.3.' Design and de#elopment #alidation "e#er$% S&b*c%$&'e De'cr()t(o#: /esign and development validation shall be performed in accordance with planned arrangements (see 3..) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where 5nown. "herever practicable, validation shall be completed prior to the delivery or implementation of the product. 0ecords of the results of validation and any necessary actions shall be maintained (see *.!.*). Clause #
DESCRIPTION
,.3.'
Design and de#elopment #alidation Is *es'% a* *e0el-e! 0al'*a!' e$8$-e* ! ,8'$- !"a! !"e $esul!'% $*u,! 's ,aa)le 8 -ee!'% !"e $e9u'$e-e!s 8 '!e*e* use6 ="e$e '! 's $a,!',al+ 's *es'%/*e0el-e! 0al'*a!' ,-le!e* $'$ ! *el'0e$ $ '-le-e!a!' 8 !"e $*u,!6 A$e $esul!s 8 0al'*a!' a* e,essa$ 8llu a,!'s $e,$*e* a* -a'!a'e*6 ?>.5.>7 8OTES S&cce''+&% e'(# $#/or Deve%o)e#t ver(+(c$t(o# )recee' De'(# $#/or eve%o)e#t v$%($t(o#. A''&re $%($t(o# (' #or$%% )er+ore er e+(#e o)er$t(# co#(t(o#'. It $ be #ece''$r to )er+or $%($t(o# (# e$r%(er 't$e' )r(or to )ro&ct co)%et(o# (t (' #or$%% )er+ore o# te +(#$% )ro&ct b&t &%t()%e v$%($t(o#' $ be )er+ore (+ tere $re (++ere#t (#te#e &'e'.
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
Clause #
DESCRIPTION
,.3.'.1 AS9100
Documentation of Design and/or de#elopment 0erification and 0alidation
AS9100
A''&re te or$#(4$t(o# $' $t te co)%et(o# o+ e'(# $#/or eve%o)e#t re)ort' c$%c&%$t(o#' te't re'&%t' etc. t$t eo#'tr$te t$t te )ro&ct e+(#(t(o# (' (# $ccor$#ce 3(t te ')ec(+(c$t(o# re-&(ree#t' +or $%% (e#t(+(e o)er$t(o#$% co#(t(o#'.
Clause #
DESCRIPTION
,.3.'.2 AS9100
De'(# $#/or Deve%o)e#t er(+(c$t(o# $# $%($t(o# Te't(#: >e# te't' $re )er+ore +or ver(+(c$t(o# $# v$%($t(o# te'e te't' '$%% be )%$##e co#tro%%e rev(e3e $# oc&e#te to $''&re te +o%%o3(#: $. te't )%$#' or ')ec(+(c$t(o#' (e#t(+ te )ro&ct be(# te'te $# te re'o&rce' be(# &'e e+(#e te't ob?ect(ve' $# co#(t(o#' )$r$eter' to be recore $# re%ev$#t $cce)t$#ce cr(ter($= b. te't )roce&re' e'cr(be te eto o+ o)er$t(o# te )er+or$#ce o+ te te't $# te recor(# o+ te re'&%t'= c. te correct co#+(&r$t(o# 't$#$r o+ te )ro&ct (' '&b(tte +or te te't= . te re-&(ree#t' o+ te te't )%$# $# te te't )roce&re' $re ob'erve= e. te $cce)t$#ce cr(ter($ $re et.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e ,.3., Control of design and de#elopment c%anges "e#er$% S&b*c%$&'e De'cr()t(o#: /esign and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. 0ecords of the results of the review of changes and any necessary actions shall be maintained (see *.!.*). Clause #
DESCRIPTION
,.3.,
Control of design and de#elopment c%anges A$e *es'% a* *e0el-e! ,"a%es '*e!'8'e* a* $e,$*e*6 A$e all *es'% a* / $ *e0el-e! ,"a%es $e0'ee*+ 0e$'8'e* a* 0al'*a!e*+ as a$$'a!e+ a* a$0e* $'$ ! '-le-e!a!'6 A$e !"e$e e0alua!'s/$e0'es 8 !"e e88e,!s 8 !"e ,"a%es ,s!'!ue! a$!s a* *el'0e$e* $*u,!s6 A$e !"e$e $e,$*s 8 !"e $esul!s 8 !"e $e0'es 8 ,"a%es6 A$e !"e$e $e,$*s 8 a e,essa$ a,!'s '*e!'8'e* as a $esul! 8 !"e ,"a%e $e0'e $,ess6 *es !"e $%a'(a!' -a'!a' !"ese $e,$*s6 H$' te or$#(4$t(o#@' c$#e co#tro% )roce'' )rov(e +or c&'toer $#/or re&%$tor $&tor(t $))rov$% o+ c$#e' 3ere re-&(re b co#tr$ct or re&%$tor re-&(ree#t5
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE ,.4 !urc%asing S&b*c%$&'e ,.4.1 !urc%asing process "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall ensure that purchased product conforms to specified purchase requirements. The type and e-tent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization6s requirements. #riteria for selection, evaluation and re2evaluation shall be established. 0ecords of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see *.!.*).
Clause # DESCRIPTION ,.4.1
AS9100
AS9100
!urc%asing process *es !"e $%a'(a!' ,!$l '!s u$,"as'% $,esses ! esu$e u$,"ase* $*u,! ,8$-s ! se,'8'e* $e9u'$e-e!s6 Des !"e !e a* e@!e! 8 ,!$l e@e$,'se* ) !"e $%a'(a!' *ee* u !"e e88e,! s u)se9ue! $*u,! $eal'(a!' $,esses $ !"e 8'al $*u,!6 I' te or$#(4$t(o# re')o#'(b%e +or te -&$%(t o+ $%% )ro&ct' )&rc$'e +ro '&))%(er' (#c%&(# c&'toer*(e#t(+(e 'o&rce'5
Des !"e $%a'(a!' e0alua!e a* sele,! sul'e$s )ase* !"e'$ a)'l'! ! sul $*u,! ' a,,$*a,e '!" !"e $%a'(a!' $e9u'$e-e!s6 ="a! 's !"e ,$'!e$'a !"e $%a'(a!' uses 8$ !"e sele,!'+ e0alua!'+ a* $ee0alua!' 8 sul'e$s6 A$e !"e $esul!s 8 e0alua!'s a* su)se9ue! 8ll u a,!'s $e,$*e* a* -a'!a'e*6 ?>.5.>7 er(+ te or$#(4$t(o#: $. $(#t$(#' $# $))rove '&))%(er' %('t t$t (#c%&e' te e
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
3(t '&))%(er' +$(%(# to eet re-&(ree#t'= . Are c&'toer $))rove ')ec($% )roce'' 'o&rce' &'e 3ere re-&(re +or bot te or$#(4$t(o# $# $%% '&))%(er'5 e. A''&re te +ct(o#$% ro&) re')o#'(b%e +or $))rov(# '&))%(er -&$%(t ''te' $' te $&tor(t to ('$))rove te &'e o+ 'o&rce'.
S&b*c%$&'e ,.4.2 !urc%asing information "e#er$% S&b*c%$&'e De'cr()t(o#: urchasing information shall describe the product to be purchased, including where appropriate a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. Clause #
DESCRIPTION
,.4.2
!urc%asing information Des u$,"as'% *,u-e!s ,!a' '8$-a!' *es,$')'% !"e $*u,! ! )e u$,"ase*+ ',lu*'% "e$e a$$'a!e4 a7 Re9u'$e-e!s 8$ a$0al 8 4 P$*u,!6 P$,e*u$es6 P$,esses6 E9u'-e!6 -
AS9100
)7 Qual'8',a!' 8 e$sel6 ,7 Qual'! -aa%e-e! ss!e- $e9u'$e-e!s6 d). )o'(t(ve (e#t(+(c$t(o# $# )ert(#e#t (''&e' o+ ')ec(+(c$t(o#' r$3(#' )roce'' re-&(ree#t' (#')ect(o# (#'tr&ct(o#' $# oter ()ort$#t tec#(c$% $t$ e. re-&(ree#t' +or e'(# te't e<$(#$t(o# (#')ect(o# $# (#+or$t(o# +or $cce)t$#ce +. re-&(ree#t' +or te't ')ec(e#' ;e.. )ro&ct(o# eto #&ber 'tor$e co#(t(o#', +or e'(# $))rov$% (#')ect(o# (#ve't($t(o# or $&(t(# . (#+or$t(o# $' re-&(re to $''&re * #ot(+(c$t(o# b '&)) %(er o+ #o#co#+or(# )ro&ct $# * re-&(ree#t' +or or$#(4$t(o# $))rov$% o+ '&))%(er #o#co#+or(# $ter($%
AS9100
%. supplier to notification of c%anges in product and/or process definition and$ (%ere necessary$
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
otain organi-ation appro#al$
AS9100
(. c&'toer or$#(4$t(o# $# re&%$tor $&tor(t(e' $cce'' to $%% +$c(%(t(e' (#vo%ve (# te orer $# to $%% $))%(c$b%e recor' $# ?. re-&(ree#t' +or te '&))%(er to +%o3 o3# to '&b*t(er '&))%(er' te #ece''$r re-&(ree#t' (# te )&rc$'(# oc&e#t' (#c%&(# 6e c$r$cter('t(c' $' re-&(re. *es !"e $%a'(a!' esu$e !"e a*e9ua, 8 se,'8'e* u$,"ase $e9u'$e-e!s ' !"e u$,"as'% *,u-e!s $'$ ! !"e'$ $elease ! !"e sul'e$6
S&b*c%$&'e ,.4.3 0erification of purc%ased product "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. "here the organization or its customer intends to perform verification at the supplier6s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information. Clause #
DESCRIPTION
,.4.3 AS9100
0erification of purc%ased product A''&re te or$#(4$t(o# eve%o)e $# ()%ee#t' (#')ect(o# or oter $ct(v(t(e' $' #ece''$r +or ver(+(c$t(o# t$t te )&rc$'e )ro&ct eet' te ')ec(+(e )&rc$'e re-&(ree#t'5 >ere ver(+(c$t(o# (' $cco)%('e $t te '&))%(er'@ +$c(%(t oe' te or$#(4$t(o# (e#t(+ te ver(+(c$t(o# re-&(ree#t' $# eto o+ )ro&ct re%e$'e $' )$rt o+ te )&rc$'(# (#+or$t(o#5
AS9100
o''(b%e ver(+(c$t(o# eto' (#c%&e $. ob?ect(ve ev(e#ce o+ te -&$%(t o+ te )ro&ct +ro '&))%(er' ;e.. $cco)$#(# oc&e#t$t(o# cert(+(c$te o+ co#+or(t te't re)ort' 't$t('t(c$% recor' )roce'' co#tro%, b. (#')ect(o# $# $&(t $t '&))%(er@' +$c(%(t c. oc&e#t$t(o# rev(e3 $' re-&(re . rece(v(# )ro&ct (#')ect(o# $# e. e%e$t(o# to te '&))%(er or '&))%(er cert(+(c$t(o#. A''&re )&rc$'e )ro&ct (' #ot &'e or )roce''e t(% (t $' bee# ver(+(e $' eet(# ')ec(+(e re-&(ree#t' %e'' (t (' re%e$'e er )o'(t(ve rec$%% )roce&re. er(+ 3ere te't re)ort' $re &'e to $''&re )&rc$'e )ro&ct te $t$ (# to'e re)ort' (' $cce)t$b%e )er $))%(c$b%e ')ec(+(c$t(o#'. er(+ te or$#(4$t(o# )er(o(c$%% v$%($te' te't re)ort' +or r$3 $ter($%. A''&re e%e$t(o# ver(+(c$t(o# +or te '&))%(er (' e+(#e $# $ %('t o+ e%e$t(o#' $(#t$(#e.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE ,.5 !roduction and ser#ice pro#ision S&b*c%$&'e ,.5.1 Control of production and ser#ice pro#ision "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall plan and carry out production and service provision under controlled conditions. #ontrolled conditions shall include, as applicable a) the availability of information that describes the characteristics of the product, b) the availability of wor5 instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post2delivery activities. Clause #
DESCRIPTION
,.5.1 AS9100
Control of production and ser#ice pro#ision A''&re )%$##(# $re''e' $' $))%(c$b%e * te e't$b%('e#t o+ )roce'' co#tro%' $# eve%o)e#t o+ co#tro% )%$#' 3ere 6e c$r$cter('t(c' $ve bee# (e#t(+(e * te (e#t(+(c$t(o# o+ (#*)roce'' ver(+(c$t(o# )o(#t' 3ere te c$##ot be )er+ore $t $ %$ter 't$e o+ )ro&ct b&(% * te e'(# $#&+$ct&re $# &'e o+ too%(# 'o t$t v$r($b%e e$'&ree#t' c$# be t$6e# )$rt(c&%$r% +or 6e c$r$cter('t(c' $# * ')ec($% )roce''e' ;'ee 7..2,.
="a! a$e !"e ,!$lle* ,*'!'s !"e $%a'(a!' uses ! la a* ,a$$ u! $*u,!' a* se$0',e e$a!'6 *es !"e $%a'(a!' ,!$l !"e 8ll'% $*u,!' / se$0',e ,*'!'s ?as al',a)le7 a7 !"e a0a'la)'l'! 8 '8$-a!' !"a! se,'8'es !"e ,"a$a,!e$'s!',s 8 !"e $*u,!: )7 "e$e e,essa$+ !"e a0a'la)'l'! 8 $B 's!$u,!'s:
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
AS9100
,7 !"e use 8 su'!a)le e9u'-e! *7 !"e a0a'la)'l'! a* use 8 -'!$'% a* -easu$'% *e0',es: e7 !"e '-le-e!a!' 8 -'!$'% a* -easu$e-e! a,!'0'!'es: +, &r(# re%e$'e e%(ver $# )o't*e%(ver eto'. . $ccot$b(%(t +or $%% )ro&ct &r(# $#&+$ct&re ;e.. )$rt' -&$#t(t' ')%(t orer' #o#co#+or(# )ro&ct, . ob?ect(ve ev(e#ce t$t $%% $#&+$ct&r(# $# (#')ect(o# re-&(ree#t' $re $cco)%('e $' )%$##e or oc&e#te $# $&tor(4e (. A eto to $re'' )reve#t(o# etect(o# $# reov$% o+ +ore(# ob?ect'
?. o#(tor(# $# co#tro% o+ &t(%(t(e' $# '&))%(e' '&c $' 3$ter co)re''e $(r e%ectr(c(t $# ce(c$% )ro&ct' $' te e++ect )ro&ct -&$%(t $# 6. cr(ter($ +or 3or6$#'() 3(c '$%% be 't()&%$te (# c%e$r )r$ct(c$% ter' ;e.. 3r(tte# 't$#$r' re)re'e#t$t(ve '$)%e' or (%%&'tr$t(o#',.
Clause #
DESCRIPTION
,.5.1.1 AS9100
ro&ct(o# Doc&e#t$t(o#: er(+ ro&ct(o# o)er$t(o#' $re (# $ccor$#ce 3(t $))rove $t$. T(' $t$ '$%% co#t$(# $' #ece''$r: a. dra(ings$ parts lists$ process flo( c%arts including inspection operations$ production documents e.g.$ manufacturing plans$ tra#eler$ router$ (or+ order$ process cards and i nspection documents see .2.4.1$ and
b. $ %('t o+ ')ec(+(c or #o#*')ec(+(c too%' $# #&er(c$% co#tro% ;8C, $c(#e )ror$' re-&(re $# $# ')ec(+(c (#'tr&ct(o#' $''oc($te 3(t te(r &'e. Co#tro% o+ ro&ct(o# roce'' C$#e': er'o#' $&tor(4e to $))rove c$#e' to )ro&ct(o# )roce''e' '$%% be (e#t(+(e.
,.5.1.2 AS9100
,.5.1.3 AS9100
A''&re te or$#(4$t(o# $' (e#t(+(e $# obt$(#e $cce)t$#ce o+ c$#e' t$t re-&(re c&'toer $#/or re&%$tor $&tor(t $))rov$% (# $ccor$#ce 3(t co#tr$ct or re&%$tor re-&(ree#t'. A''&re c$#e' $++ect(# )roce''e' )ro&ct(o# e-&()e#t too%' $# )ror$' $re oc&e#te. er(+ )roce&re' $re $v$(%$b%e to co#tro% ()%ee#t$t(o# o+ c$#e'. A''&re te re'&%t' o+ c$#e' to )ro&ct(o# )roce''e' $re $''e''e to ver(+ te e'(re e++ect (' $cco)%('e 3(to&t $ver'e e++ect' to )ro&ct -&$%(t. A''&re oc&e#te )roce&re' $re (# )%$ce +or te Co#tro% o+ ro&ct(o# E-&()e#t Too%' $# 8&er(c$% Co#tro% ;8.C., M$c(#e ror$' $# )ror$' $re v$%($te )r(or to &'e $# $(#t$(#e $# (#')ecte )er(o(c$%%. A''&re v$%($t(o# )r(or to )ro&ct(o# (#c%&e'
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
ver(+(c$t(o# o+ te +(r't $rt(c%e )ro&ce to te e'(# $t$/')ec(+(c$t(o#. A''&re 'tor$e re-&(ree#t' (#c%&(# )er(o(c )re'erv$t(o#/co#(t(o# cec6' $re e't$b%('e +or )ro&ct(o# e-&()e#t or too%(# (# 'tor$e.
,.5.1.4 AS9100
A''&re te or$#(4$t(o# $' Co#tro% o+ >or6 Tr$#'+erre o# $ Te)or$r B$'(' O&t'(e te Or$#(4$t(o#@' $c(%(t(e': A''&re )%$##(# +or 3or6 te)or$r(% tr$#'+erre $' $ e+(#e )roce'' to co#tro% $# . v$%($te te -&$%(t o+ te 3or6 Co#tro% o+ Serv(ce O)er$t(o#': >ere 'erv(c(# (' ')ec(+(e ver(+ 'erv(ce o)er$t(o# )roce''e' )rov(e +or $. $ eto $t$ co%%ect(o# $# $#$%'(' o+ (#* 'erv(ce $t$
,.5.1.5 AS9100
b. )o't*e%(ver $ct(o#' +or )rob%e' (#c%&(# (#ve't($t(o# re)ort(# $ct(v(t(e' $# $ct(o#' o# 'erv(ce (#+or$t(o# co#'('te#t 3(t co#tr$ct&$% $#/or re&%$tor re-&(ree#t' c. &)$t(# co#tro% $# o+ tec#(c$% $t$ . te $))rov$% co#tro% $# &'e o+ re)$(r )%$#' $# e. te co#tro%' re-&(re +or o++*'(te 3or6
S&b*c%$&'e ,.5.2 0alidation of processes for production and ser#ice pro#ision "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall validate any processes for production and service provision where subsequent monitoring or measurement cannot verify the resulting output. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. 9alidation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see *.!.*), and e) revalidation.
Clause #
DESCRIPTION
,.5.2
0alidation of processes for production and ser#ice pro#ision Processes require validation when the resulting output cannot be verified by subsequent measurement or monitoring. This includes any process where deficiencies may become apparent only after the product is in use or the service has been delivered. as !"e $%a'(a!' '*e!'8'e* a $*u,!' a*/$ se$0',e $,esses "'," $e9u'$es ! )e 0al'*a!e*6 I8 $,esses "a0e )ee '*e!'8'e*+ "as !"e $%a'(a!' *e8'e*4 a7 !"e ,$'!e$'a 8$ $e0'e a* a$0al 8 !"e $,esses6 A''&re $))rov$% $# -&$%(+(c$t(o# o+ ')ec($% )roce''e' )r(or to &'e
NOTE4
AS9100
AS9100
)7 a$0al 8 e9u'-e! use* a* 9ual'8',a!'s 8 e$sel6 ,7 use 8 se,'8', -e!"*s a* $,e*u$es6 H$' te or$#(4$t(o# co#tro%%e te '(#(+(c$#t o)er$t(o#' $# )$r$eter' o+ ')ec($% )roce''e' (# $ccor$#ce 3(t oc&e#te )roce'' ')ec(+(c$t(o#' $# c$#e'5
*7 $e9u'$e-e!s 8$ $e,$*s ?>.5.>76 e7 $e0al'*a!' 8 $,ess $e9u'$e-e!s6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e ,.5.3 &dentification and traceaility "e#er$% S&b*c%$&'e De'cr()t(o#: "here appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. "here traceability is a requirement, the organization shall control and record the unique identification of the product (see *.!.*). $%T& In some industry sectors, configuration management is a means by which identification and traceability are maintained.
Clause #
DESCRIPTION
,.5.3
&dentification and traceaility Des !"e $%a'(a!' '*e!'8+ "e$e a$$'a!e+ !"e $*u,! ) su'!a)le -eas !"$u%"u! $*u,!' $eal'(a!'6 A''&re te or$#(4$t(o# $(#t$(#' te (e#t(+(c$t(o# o+ te co#+(&r$t(o# o+ te )ro&ct (# orer to (e#t(+ $# (++ere#ce' bet3ee# te $ct&$% $# $ree co#+(&r$t(o#. Des !"e $%a'(a!' '*e!'8 $*u,! s!a!us '!" $ese,! ! '!s -'!$'% a* -easu$e-e! $e9u'$e-e!s6 A''&re $cce)t$#ce $&tor(t eto' 3e# &'e $re ;e.. 't$)' e%ectro#(c '(#$t&re' )$''3or', oc&e#te $# co#tro%%e Des !"e $%a'(a!' ,!$l a* $e,$* !"e u'9ue '*e!'8',a!' 8 !"e $*u,!+ "e$e !$a,ea)'l'! 's a $e9u'$e-e!6 ?>.5.>7 A''&re te or$#(4$t(o#@' ''te b$'e o# te %eve% o+ tr$ce$b(%(t re-&(re b co#tr$ct re&%$tor or oter e't$b%('e re-&(ree#t )rov(e' +or: $. (e#t(+(c$t(o# tro&o&t te )ro&ct %(+e= b. tr$ce$b(%(t +or $%% te )ro&ct' $#&+$ct&re +ro te '$e b$tc o+ r$3 $ter($% or +ro te '$e $#&+$ct&r(# b$tc $' 3e%% $' te e't(#$t(o# ;e%(ver 'cr$), o+ $%% )ro&ct' o+ te '$e b$tc= c. tr$ce$b(%(t +or $# $''eb% te (e#t(t o+ (t' co)o#e#t' $# to'e o+ te #e
AS9100
AS9100
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
be )rov(e.
S&b*c%$&'e ,.5.4 Customer property "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall e-ercise care with customer property while it is under the organization6s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see *.!.*). $ote' #ustomer property can include intellectual property Clause #
DESCRIPTION
,.5.4
Customer property ="a! a$e !"e $,esses / $,e*u$es !"a! a**$ess !"e $%a'(a!'s $ess')'l'! ! e@e$,'se ,a$e '!" ,us!-e$ $e$! "'le '! 's u*e$ !"e $%a'(a!'Js ,!$l $ )e'% use* ) !"e $%a'(a!'6 Des !"e $,esses/$,e*u$e a**$ess 8ll'% 'ssues $ela!e* ! ,us!-e$ $e$!4 a7 '*e!'8',a!' )7 0e$'8',a!' ,7 $!e,!' *7 sa8e%ua$*'% 8$- use $ ',$$a!' '! $*u,! Des !"e $,ess/$,e*u$e esu$e !"a! a ,us!-e$ $e$! !"a! 's ls!+ *a-a%e* $ !"e$'se 8u* ! )e usu'!a)le 8$ use 's $e$!e* ! !"e ,us!-e$6 A$e !"e $e,$*s ,us!-e$ $e$! !"a! 's ls!+ *a-a%e* $ !"e$'se 8u* ! )e usu'!a)le 8$ use -a'!a'e* ) !"e $%a'(a!'6 Cus!-e$ $e$! als ',lu*es a s8!a$e a*/$ '!elle,!ual $e$!+ "'," a$e $0'*e* ! !"e $%a'(a!'. . (#c%&(# c&'toer +&r#('e $t$ &'e +or e'(# )ro&ct(o# $#/or (#')ect(o#
N!e4
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e ,.5.5 !reser#ation of product "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, pac5aging, storage and protection. reservation shall also apply to the constituent parts of a product. Clause #
DESCRIPTION
,.5.5
!reser#ation of product ="a! a$e !"e $,esses/$,e*u$es es!a)l's"e* ) !"e $%a'(a!' ! $ese$0e !"e ,8$-'! 8 !"e $*u,! *u$'% '!e$al $,ess'% a* *el'0e$ ! !"e '!e*e* *es!'a!'6 D !"ese $,esses/$,e*u$es a**$ess $ese$0a!' $ela!'% ! !"e a$eas 84 a7 I*e!'8',a!' 8 !"e $*u,!6 )7 a*l'% 8 !"e $*u,!6 ,7 Pa,Ba%'% 8 !"e $*u,!6 *7 S!$a%e 8 !"e $*u,!6 e7 P$!e,!' 8 !"e $*u,!6 D !"ese $ese$0a!' $,esses/$,e*u$es e@!e*e* ! !"e ,s!'!ue! a$!s 8 a $*u,! als6 A''&re 3ere $))%(c$b%e )re'erv$t(o# o+ )ro&ct (#c%&e' (# $ccor$#ce 3(t )ro&ct ')ec(+(c$t(o#' $#/or $))%(c$b%e re&%$t(o#' )rov('(o#' +or: $. c%e$#(#= b. )reve#t(o# etect(o# $# reov$% o+ +ore(# ob?ect' c. ')ec($% $#%(# +or 'e#'(t(ve )ro&ct'= . $r6(# $# %$be%(# (#c%&(# '$+et 3$r#(#'= e. 'e%+ %(+e co#tro% $# 'toc6 rot$t(o#= +. ')ec($% $#%(# +or $4$ro&' $ter($%'. A''&re te or$#(4$t(o# $(#t$(#' oc&e#t' $' re-&(re b te co#tr$ct/orer to $cco)$# te )ro&ct &r(# e%(ver $# $re )rotecte $$(#'t %o'' $# eter(or$t(o#.
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE ,.' Control of monitoring and measuring de#ices "e#er$% C%$&'e De'cr()t(o# The organization shall determine the monitoring and measurement to be underta5en and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 3.!.). The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. "here necessary to ensure valid results, measuring equipment shall a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards7 where no such standards e-ist, the basis used for calibration or verification shall be recorded7 b) be adusted or re2adusted as necessary7 c) be identified to enable the calibration status to be determined7 d) be safeguarded from adustments that would invalidate the measurement result7 e) be protected from damage and deterioration during handling, maintenance and storage. In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall ta5e appropriate action on the equipment and any product affected. 0ecords of the results of calibration and verification shall be maintained (see *.!.*). "hen used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be underta5en prior to initial use and reconfirmed as necessary. $%T& See IS% ::!2 and IS% ::!2! for guidance.
Clause #
DESCRIPTION
,.'
Control of monitoring and measuring de#ices as !"e $%a'(a!' '*e!'8'e* !"e -'!$'% a* -easu$e-e!s ! )e -a*e a* !"e - easu$'% a* -'!$'% *e0',es $e9u'$e* ! assu$e ,8$-'! 8 $*u,! ! se,'8'e* $e9u'$e-e!6 er(+ te or$#(4$t(o# $(#t$(# $ %('t o+ o#(tor(# $# e$'&r(# ev(ce' $# e+(#e' te )roce'' e)%oe +or te(r c$%(br$t(o# (#c%&(# et$(%' o+ e-&()e#t t)e (-&e (e#t(+(c$t(o# %oc$t(o# +re-&e#c o+ cec6' cec6 eto $# $cce)t$#ce cr(ter($. 8OTE Mo#(tor(# $# e$'&r(# ev(ce' (#c%&e b&t $re #ot %((te to: te't $r3$re te't 'o+t3$re $&to$te te't e-&()e#t ;ATE, $# )%otter' &'e to )ro&ce (#')ect(o# $t$. It $%'o (#c%&e' )er'o#$%% o3#e $# c&'toer '&))%(e e-&()e#t &'e to )rov(e ev(e#ce o+ )ro&ct co#+or(t . *es !"e $%a'(a!' esu$e !"a! !"e -easu$e-e!s a* -'!$'% ,a )e a* a$e ,a$$'e* u! ' a -ae$ !"a! 's ,s's!e! '!" !"e -'!$ a* -easu$e-e! $e9u'$e-e!s6 A''&re te or$#(4$t(o# ver(+(e' e#v(ro#e#t$% co#(t(o#' $re '&(t$b%e +or te c$%(br$t(o#' (#')ect(o#' e$'&ree#t' $# te't' be(# c$rr(e o&t. *es !"e $%a'(a!' esu$e !"a! !"e -easu$'% a* -'!$'% *e0',es '*e!'8'e* "a0e !"e ,aa)'l'! ! ,a$$'e* u! a* ! ,!'ue ! "a0e !"e a)'l'! ! ,a!u$e !"e -'!$ a* -easu$e-e! $e9u'$e-e!s6 ="e$e e,essa$ ! esu$e 0al'* $esul!s+ a$e !"e -easu$'% a* -'!$'% *e0',es4 a7 ,al')$a!e* a* a*
AS9100
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
*7 sa8e%ua$*e* 8$- a*
e7 $!e,!e* 8$- *a-a%e a* *e!e$'$a!' *u$'% AS9100
"a*l'%+ -a'!ea,e a* s!$a%e6 +,. A''&re $ '&(t$b%e rec$%% eto (' &'e as !"e $%a'(a!'4 a7 assesse* a* $e,$*e* !"e 0al'*'! 8 $e0'us -easu$e-e!s "e e9u'-e! 's 8u* ! ! ,8$- ! $e9u'$e-e!s6 )7 !aBe a$$'a!e a,!' !"e e9u'-e! ! esu$e '! ,8$-s ! $e9u'$e-e!s6 ,7 !aBe a$$'a!e a,!' a $*u,! a88e,!e* ) $esul!s )!a'e* 8$- !"e ! ,8$-'% e9u'-e!. A$e $e,$*s 8 !"e $esul!s 8 ,al')$a!'s a* 0al'*a!'s -a'!a'e* ) !"e $%a'(a!'6 ?>.5.>7 Des !"e $%a'(a!' use s8!a$e ! -'!$ a*/$ -easu$e se,'8'e* $e9u'$e-e!s6 as !"e a)'l'! 8 !"'s s8!a$e ! sa!'s8 !"e '!e*e* al',a!' )ee ,8'$-e* $'$ ! '!s ''!'al use6 a* "e *es !"e $%a'(a!' $e,8'$- !"e a)'l'! 8 !"'s s8!a$e ! ,!'ue ! sa!'s8 !"e '!e*e* al',a!'6
CLAUSE Measurement$ analysis and impro#ement CLAUSE .1 General "e#er$% C%$&'e De'cr()t(o# The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed a) to demonstrate conformity of the product, b) to ensure conformity of the quality management system, and c) to continually improve the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the e-tent of their use.
Clause #
DESCRIPTION
.1
General as !"e $%a'(a!' es!a)l's"e* a* '-le-e!e* las ! -'!$+ -easu$e+ aals's a* '-$0e-e! $,esses ee*e* !4 a7 *e-s!$a!e ,8$-'! 8 !"e $*u,!6 )7 esu$e ,8$-''! 8 !"e 9ual'! -aa%e-e! ss!e- ?QMS76 ,7 ,!'uall '-$0e !"e e88e,!'0eess 8 !"e QMS6 as !"e $%a'(a!' *e!e$-'e* !"e al',a)le -e!"*s ee*e* ! esu$e ,8$-'! a* a,"'e0e '-$0e-e!6 as !"e $%a'(a!' 's!'!u!e* !"se -e!"*s ee*e* ! esu$e ,8$-'! a* a,"'e0e '-$0e-e!6 D !"se -e!"*s '*',a!e !"e e@!e! 8 !"e'$ use6 8OTE De)e#(# o# te ')ec(+(e re-&(ree#t' $# te #$t&re o+ te )ro&ct $# 't$t('t(c$% tec#(-&e' $ be &'e to '&))ort: e'(# ver(+(c$t(o# ;e.. re%($b(%(t $(#t$(#$b(%(t '$+et,= )roce'' co#tro%: 'e%ect(o# $# (#')ect(o# o+ 6e c$r$cter('t(c'= )roce'' c$)$b(%(t e$'&ree#t'= 't$t('t(c$% )roce'' co#tro%= e'(# o+ e<)er(e#t= (#')ect(o# * $tc(# '$)%(# r$te to te cr(t(c$%(t o+ te )ro&ct $# to te )roce'' c$)$b(%(t= +$(%&re oe $# e++ect $#$%'(' .
AS9100
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE .2 Monitoring and measurement S&b*c%$&'e .2.1 Customer satisfaction "e#er$% S&b*c%$&'e De'cr()t(o#: 1s one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. Clause #
DESCRIPTION
.2.1
Customer satisfaction as !"e $%a'(a!' *e!e$-'e* !"e -e!"*l%'es '! 'll use 8$ )!a''% '8$-a!' ,us!-e$ sa!'s8a,!'6 Des !"e $%a'(a!' -'!$ !"se -e!"*l%'es as e 8 !"e -easu$e-e!s 8 e$8$-a,e 8 !"e Qual'! Maa%e-e! Ss!e-6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e .2.2 &nternal audit "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see 3.), to the requirements of this International Standard and to the quality management system requirements established by the organization, and b) is effectively implemented and maintained. 1n audit programme shall be planned, ta5ing into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure obectivity and impartiality of the audit process. 1uditors shall not audit their own wor5. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see *.!.*) shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are ta5en without undue delay to eliminate detected nonconformities and their causes. ;ollow2up activities shall include the verification of the actions ta5en and the reporting of verification results (see 4.<.!). $%T& See IS% ::2, IS% ::2! and IS% ::2 for guidance.
Clause #
DESCRIPTION
.2.2
&nternal audit as !"e $%a'(a!' se! u a ss!e- ! ,*u,! '!e$al au*'!s a! lae* '!e$0als6 Des !"e $%a'(a!' ,*u,! !"se '!e$al au*'!s as lae*6 D !"ese '!e$al au*'!s ,0e$ !"e $e9u'$e-e!s 8 !"e ISO 2331 s!a*a$* a* !"e QMS $e9u'$e-e!s es!a)l's"e* ) !"e $%a'(a!'6 Des !"e $%a'(a!'s '!e$al au*'! $,ess *e!e$-'e "e!"e$ Qual'! Maa%e-e! Ss!e-4 a7 ,8$-s ! !"e $e9u'$e-e!s 8 !"'s '!e$a!'al s!a*a$*: )7 "as )ee e88e,!'0el '-le-e!e* a* -a'!a'e*. A$e !"e au*'!s lae* ' !"e au*'! $%$a--e !aB'% '! ,s'*e$a!'4
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
a7
AS9100
!"e s!a!us a* '-$!a,e 8 !"e $,ess a* a$eas ! )e au*'!e*: )7 !"e $esul!s 8 $e0'us au*'!s. Is !"e ,$'!e$'a+ s,e+ 8$e9ue, a* -e!"*s use* ) !"e $%a'(a!' ! ,*u,! !"e au*'!s *e8'e*6 *es !"e $%a'(a!' esu$e !"a! ass'%e* au*'!$s a$e )
S&b*c%$&'e .2.3 Monitoring and measurement of processes "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. "hen planned results are not achieved, correction and corrective action shall be ta5en, as appropriate, to ensure conformity of the product. Clause #
DESCRIPTION
.2.3
Monitoring and measurement of processes A$e su'!a)le -e!"*s es!a)l's"e* 8$ -'!$'% a* -easu$e-e! 8 !"e '*e!'8'e* QMS $,esses6 D !"e -e!"*s es!a)l's"e* *e-s!$a!e !"e a)'l'! 8 !"e $,ess ! a,"'e0e lae* $esul!s6 >ere #o#*co#+or$#ce' occ&r $re correct(o#' $# correct(ve $ct(o#' t$6e#5 I+ $ )roce'' #o#co#+or(t occ&r' ver(+ te or$#(4$t(o# $. t$6e' $))ro)r($te $ct(o# to correct te #o#co#+or(# )roce'' b. ev$%&$te 3eter te )roce'' #o#co#+or(t $' re'&%te (# )ro&ct #o#co#+or(t $# c. (e#t(+ $# co#tro% te #o#co#+or(# )ro&ct (# $ccor$#ce 3(t c%$&'e ..
AS9100
="e lae* $esul!s a$e ! a,"'e0e*+ a$e ,$$e,!'s a* ,$$e,!'0e a,!'s !aBe6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e .2.4 Monitoring and measurement of product "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 3.). &vidence of conformity with the acceptance criteria shall be maintained. 0ecords shall indicate the person(s) authorizing release of product (see *.!.*). roduct release and service delivery shall not proceed until the planned arrangements (see 3.) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Clause #
DESCRIPTION
.2.4
Monitoring and measurement of product Des !"e $%a'(a!' -'!$ a* -easu$e $*u,! ,"a$a,!e$'s!',s ! 0e$'8 !"e -ee! !"e $e9u'$e-e!s 8$ !"e $*u,!6 as !"e $%a'(a!' es!a)l's"e* a$$'a!e s!a%es ' !"e $*u,! $eal'(a!' $,ess ! -'!$ a* -easu$e $*u,! ,"a$a,!e$'s!',s6 A$e -'!$'% a* -easu$e-e! a,!'0'!'es )e'% ,a$$'e* u! a! a$$'a!e s!a%es 8 !"e $*u,! $eal'(a!' $,ess ' a,,$*a,e '!" !"e lae* a$$a%e-e!s6 A' $))%(c$b%e $''&re 6e c$r$cter('t(c' $ve bee# (e#t(+(e o#(tore $# co#tro%%e
AS9100
AS9100
Is !"e$e e0'*e,es ! ,8'$- !"a! $*u,! ,"a$a,!e$'s!',s -ee! !"e $e9u'$e-e!s 8$ !"e $*u,!6 Is !"e e0'*e,e 8 ,8$-'! '!" !"e a,,e!a,e ,$'!e$'a *,u-e!e* a* -a'!a'e*6 D $*u,! $e,$*s '*',a!e !"e e$s?s7 au!"$'('% $elease 8 !"e $*u,!6 A''&re o#% co#+or(# )ro&ct (' &'e $+ter (t $' bee# (#')ecte or oter3('e ver(+(e $' to ')ec(+(e re-&(ree#t' e
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
Clause #
DESCRIPTION
.2.4.1
I#')ect(o# Doc&e#t$t(o#: A''&re e$'&ree#t re-&(ree#t' +or )ro&ct or 'erv(ce $cce)t$#ce $re oc&e#te. T(' oc&e#t$t(o# $ be )$rt o+ te )ro&ct(o# oc&e#t$t(o# ver(+ $' +o%%o3':: $. I' tere cr(ter($ +or $cce)t$#ce $#/or re?ect(o#5 b. Are te 'e-&e#ce e$'&ree#t $# te't(# o)er$t(o#' $re )er+ore5 c. I' tere $ recor o+ te e$'&ree#t re'&%t' $# . t)e o+ e$'&ree#t (#'tr&e#t' re-&(re $# $# ')ec(+(c (#'tr&ct(o#' $''oc($te 3(t te(r &'e5 Do te't recor' 'o3 $ct&$% te't re'&%t' $t$ 3e# re-&(re b ')ec(+(c$t(o# or $cce)t$#ce te't )%$#. Do )ro&ct -&$%(+(c$t(o# recor' )rov(e ev(e#ce t$t te )ro&ct eet te e+(#e re-&(ree#t'5
AS9100
F.5.>.5 AS9100
(r't Art(c%e I#')ect(o#: Te or$#(4$t(o#@' ''te '$%% )rov(e $ )roce'' +or te (#')ect(o# ver(+(c$t(o# $# oc&e#t$t(o# o+ $ re)re'e#t$t(ve (te +ro te +(r't )ro&ct(o# r o+ $ #e3 )$rt or +o%%o3(# $# '&b'e-&e#t c$#e t$t (#v$%($te' te )rev(o&' +(r't $rt(c%e (#')ect(o# re'&%t. 8OTE See ;AS, ;E8, ;SFAC, 9102 +or &($#ce.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE .3 Control of nonconforming product "e#er$% C%$&'e De'cr()t(o# The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or more of the following ways' a) by ta5ing action to eliminate the detected nonconformity7 b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer7 c)
by ta5ing action to preclude its original intended use or application.
0ecords of the nature of nonconformities and any subsequent actions ta5en, including concessions obtained, shall be maintained (see *.!.*). "hen nonconforming product is corrected it shall be subect to re2verification to demonstrate conformity to the requirements. "hen nonconforming product is detected after delivery or use has started, the organization shall ta5e action appropriate to the effects, or potential effects, of the nonconformity.
Clause #
DESCRIPTION
.3
Control of nonconforming product Des !"e $%a'(a!' "a0e a *,u-e!e* $,e*u$e "'," esu$es ! ,8$-'% $*u,! 's '*e!'8'e*+ ,!$lle*+ a* $e0e!e* 8$- u'!e*e* use $ *el'0e$6 8OTE Te ter G#o#co#+or(# )ro&ct (#c%&e' #o#co#+or(# )ro&ct ret&r#e +ro $ c&'toer.
AS9100
A''&re te or$#(4$t(o#@' oc&e#te )roce&re e+(#e' te re')o#'(b(%(t +or rev(e3 $# $&tor(t +or te (')o'(t(o# o+ #o#co#+or(# )ro&ct $# te )roce'' +or $))rov(# )er'o##e% $6(# te'e ec('(o#'.
AS9100
A$e !"e ,!$ls+ $ela!e* $ess')'l'!'es+ a* au!"$'! 8$ *eal'% '!" ,8$-'% *e8'e* ' a *,u-e!e* $,e*u$e6 Des !"e *,u-e!e* $,e*u$e a**$ess !"e 8ll'% 4 a7 a,!' !aBe ! el'-'a!e !"e *e!e,!e* ,8$-'!6 )7 au!"$'(e* use+ $elease $ a,,e!a,e u*e$ ,,ess' ) $ele0a! au!"$'! a*/$ ,us!-e$6 ,7 !aB'% a,!' ! $e,lu*e '!s $'%'al '!e*e* use $ al',a!'6 H$' te or$#(4$t(o# &'e (')o'(t(o#' o+ &'e*$'*(' or re)$(r 3(to&t be(# $&tor(4e b te c&'toer5 er(+ te )ro&ct (' )ro&ce to c&'toer e'(# or te #o#co#+or(t re'&%t' (# $ e)$rt&re +ro te co#tr$ct re-&(ree#t'. U#%e'' oter3('e re'tr(cte (# te co#tr$ct or$#(4$t(o#*e'(#e )ro&ct 3(c (' co#tro%%e v($ $ c&'toer ')ec(+(c$t(o# $ be (')o'(t(o#e b te or$#(4$t(o# $' &'e*$'*(' or re)$(r )rov(e te #o#co#+or(t oe' #ot re'&%t (# $ e)$rt&re +ro c&'toer*')ec(+(e re-&(ree#t'.
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
AS9100
AS9100
Are $%% )ro&ct' (')o'(t(o#e +or 'cr$) co#')(c&o&'% $# )er$#e#t% $r6e or )o'(t(ve% co#tro%%e t(% )'(c$%% re#ere &'$b%e5 Des !"e $%a'(a!' -a'!a' $e,$*s 8 ,8$-a,e+ su)se9ue! a,!'s !aBe a* ,,ess's )!a'e*6 ="e ,8$-'% $*u,! 's ,$$e,!e* 's '! su)
CLAUSE
.4 nalysis of data
"e#er$% C%$&'e De'cr()t(o# The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to d) customer satisfaction (see 4.!.), e) conformity to product requirements (see 3.!.), f) characteristics and trends of processes and products including opportunities for preventive action, and d) suppliers. Clause #
DESCRIPTION
.4
nalysis of data Des !"e $%a'(a!' ,lle,! a* aal(e a$$'a!e *a!a ! *e!e$-'e !"e su'!a)'l'! a* e88e,!'0eess 8 !"e Qual'! Maa%e-e! Ss!e-6 Des !"e *a!a use* 8$ aals's $0'*e '8$-a!' 4 a7 "e$e ,!'ual '-$0e-e!s 8 !"e QMS ,a )e -a*e6 )7 ,us!-e$ sa!'s8a,!' a* / $ *'ssa!'s8a,!'6 ,7 ,8$-'! ! $*u,! $e9u'$e-e!s6 *7 ,"a$a,!e$'s!',s a* !$e*s 8 $,ess+ $*u,! a* $!u'!'es 8$ $e0e!a!'0e a,!'6 e7 sul'e$s6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
CLAUSE .5 &mpro#ement S&b*c%$&'e .5.1 Continual impro#ement "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality obectives, audit results, analysis of data, corrective and preventive actions and management review. Clause #
DESCRIPTION
.5.1
Continual impro#ement Des !"e $%a'(a!' la a* -aa%e $,esses e,essa$ 8$ !"e ,!'ual '-$0e-e! !"e e88e,!'0eess 8 !"e QMS6 Des !"e $%a'(a!' use !"e 8ll'% '8$-a!' ! 8a,'l'!a!e ,!'ual '-$0e-e! 8 !"e Qual'! Maa%e-e! Ss!e-4 a7 Qual'! Pl',6 )7 Qual'! O)
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS
S&b*c%$&'e .5.2 Correcti#e action "e#er$% S&b*c%$&'e De'cr()t(o#: The organization shall ta5e action to eliminate the cause of nonconformities in order to prevent recurrence. #orrective actions shall be appropriate to the effects of the nonconformities encountered. 1 documented procedure shall be established to define requirements for a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action ta5en (see *.!.*), and f) reviewing corrective action ta5en.
Clause #
DESCRIPTION
..2
Correcti#e action as !"e $%a'(a!' es!a)l's"e* a *,u-e!e* $,e*u$e 8$ ,$$e,!'0e a,!' '!" *e8'e* $e9u'$e-e!s 8$4 a7 $e0'e'% ,-8$-'!'es ?',lu*'% ,us!-e$ ,-la'!s76 )7 *e!e$-''% !"e ,auses 8 ,8$-'!6 ,7 e0alua!'% !"e ee* 8$ a,!'s ! esu$e !"a! ,8$-'!'es * ! $e,u$6 *7 *e!e$-''% a* '-le-e!'% !"e ,$$e,!'0e a,!' ee*e*6 e7 $e,$*s 8 !"e $esul!s 8 a,!'s !aBe6
AS9100
87 $e0'e'% 8 ,$$e,!'0e a,!' !aBe. , er(+ +%o3 o3# o+ te correct(ve $ct(o# re-&e't to $ '&))%(er 3e# (t (' eter(#e t$t te '&))%(er (' re')o#'(b%e +or te root c$&'e $# $ct(o#' t$6e# 3ere t(e% $#/or e++ect(ve correct(ve $ct(o#' $re #ot $cco)%('e A$e !"e ,$$e,!'0e a,!'s !aBe a$$'a!e ! !"e '-a,! 8 !"e ,8$-'!'es e,u!e$e*6
ORGANIZATION PROCEDURE #
REV. & DATE
ADEQUACY YES / NO
COMPLIANT YES / NO
REMARKS/COMMENTS